FDA Adverse Event
Injury
Summary report: N
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28
MDR report key: 9731951
·
Received February 20, 2020
Report
- Report Number
- 3005180920-2020-00071
- Event Type
- Injury
- Date Received
- February 20, 2020
- Date of Event
- January 21, 2020
- Report Date
- February 20, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- MEH
- UDI-DI
- 07630030807343
- PMA / PMN Number
- K092265
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 18-FEB-2020: LOT 131719: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2013. EXPIRATION DATE: 2018-MAR-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AFTER ABOUT 6 YEARS FROM THE PRIMARY. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR'S HEAD AND THE MEDACTA LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 198030 | LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28 | HIP PROSTHESIS: DOUBLE MOBILITY HC LINER | MEH | MEDACTA INTERNATIONAL SA | 01.26.2852MHC | 131719 | 07630030807343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |